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Effect of TAP Block on Time Required for First Analgesic Dose After Cesarean Cection Under Spinal Anesthesia

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Transversus abdominus plane block
Transversus abdominus plane placebo
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. American Society of Anesthesiologists (ASA) class I-II
  2. Normal singleton pregnancy.
  3. With a gestational age of completed 37 weeks or more.
  4. Category ІV cesarean section

Exclusion Criteria:

  1. Under the age of 18 or older than 40 years.
  2. Obese patients with a BMI >40.
  3. ASA III or ASA IV risk groups
  4. Patients with contraindications to spinal anesthesia or history of allergy to bupivacaine.
  5. patients who received analgesics in the past 24 hours
  6. Infection in the region where the block would be performed.
  7. Category І- Ц- Ш cesarean section
  8. Refusal to participate in the study

Sites / Locations

  • AinShams university maternity hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bupivacaine

Placebo

Arm Description

the landmark is at the level of umbilicus 8 to 10 cms from midline bilaterally. A tiny nick is made in the skin with a 18G sharp needle to obliterate the cushion effect. Then an 18 G Tuohy needle will be insert perpendicular to skin directing the needle slightly towards the ipsilateral anterior superior iliac spine just before the closure of peritoneum. After feeling 2 pops of external and internal oblique aponeurosis the drug will be injected after aspiration. The injectate syringes will be prepared under aseptic technique; syringes contained bupivacaine 0.25% 40 ml. Once the plane is reached the surgeon places his hand inside the abdominal cavity at the level of needle insertion to reconfirm needle placement. A bleb is palpated by the surgeon as the injection continues. The back flow of drug after injection is one of the signs that drug has been deposited in the TAP plane

the landmark is at the level of umbilicus 8 to 10 cms from midline bilaterally. A tiny nick is made in the skin with a 18G sharp needle to obliterate the cushion effect. Then an 18 G Tuohy needle will be insert perpendicular to skin directing the needle slightly towards the ipsilateral anterior superior iliac spine just before the closure of peritoneum. After feeling 2 pops of external and internal oblique aponeurosis the drug will be injected after aspiration. The injectate syringes will be prepared under aseptic technique syringes contained either normal saline 40 ml. Once the plane is reached the surgeon places his hand inside the abdominal cavity at the level of needle insertion to reconfirm needle placement. A bleb is palpated by the surgeon as the injection continues. The back flow of drug after injection is one of the signs that drug has been deposited in the TAP plane

Outcomes

Primary Outcome Measures

Time to the first opioid analgesic request
when will the patient ask for opioid analgesia after cesarean section

Secondary Outcome Measures

Total analgesic requirements in 24 hours Total opioid analgesic requirements in 24 hours
The number of patients requiring rescue analgesia and the frequency of this analgesia and total analgesic usage will be calculated

Full Information

First Posted
November 5, 2020
Last Updated
December 22, 2022
Sponsor
Ain Shams Maternity Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04623632
Brief Title
Effect of TAP Block on Time Required for First Analgesic Dose After Cesarean Cection Under Spinal Anesthesia
Official Title
Effect of the Modified Surgeon Assisted Bilateral TAP Block on Time Required for First Analgesic Dose After Cesarean Section Under Spinal Anesthesia:A Randomized,Placebo-controlled, Double Blinded Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 20, 2020 (Actual)
Primary Completion Date
March 20, 2021 (Actual)
Study Completion Date
March 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
While opioids are the mainstay for post-operative analgesia after caesarean section, they are associated with various side effects. Ultrasound guided transversusabdominis plane (TAP) block has been postulated to provide effective analgesia for caesarean section. However a new technique in TAP block is described which can be used safely by a beginner without any fear of complication whichwill help in providing good postoperative analgesia to maximumnumber of patients. This study will evaluate the analgesic efficacy of TAP block using Modified Surgeon Assisted Bilateral TAP block for post caesarean analgesia in a randomized controlled trial.
Detailed Description
Acute severe pain after cesarean delivery is frequent. At least 10 to 15% of the women develop chronic pain .Effective postoperative analgesia after caesarean section is important because it enables early ambulation and facilitates breast-feeding. The administration of opioids, local blocks and other analgesic medication is instituted to decrease the duration and intensity of postoperative pain as a part of a multimodal analgesic regimen. The transversusabdominis plane (TAP) block is a regional analgesic technique which blocks T6-L1 nerve branches and has an evolving role in postoperative analgesia for lower abdominal surgeries . In postoperative analgesia, efficacy of TAP block is equivalent to morphine with the additional benefits of increasing duration of analgesia, reducing postoperative opioid usage, with satisfactory pain relief and few side effects. The TAP block avoids the risk of neuraxial complications and opioid complications in all patients. TAP block the neural afferents of theanterior abdominal wall after spreading of the local anesthetic agent in the neurofascial plan between the internal oblique and transversusabdominis muscle. TAP block has been underutilized in spite of having very low complication and high success rate using ultrasound technique This may be due to the lack of availability of ultrasound at most of the centers, lack of training in ultrasound guided block technique. A new technique can be used in TAP block without the fear of complications in the blind landmark based approach.The advantage of this technique includes avoiding missing the second pop in obese and pregnant patients due to thinning of the internal obliqueaponeurosis, reposition of the needle by surgeon if one enters the peritoneal cavity accidentally. Also there are nil chances of visceral injury thus can be safely used by a beginner without any fear of complication. However, there might be a chance of needle stick injury to the surgeon's hand. This study aims to evaluate effect of the Modified Surgeon Assisted Bilateral TAP block on time required for first analgesic dose after Cesarean Section under spinal anesthesia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
the landmark is at the level of umbilicus 8 to 10 cms from midline bilaterally. A tiny nick is made in the skin with a 18G sharp needle to obliterate the cushion effect. Then an 18 G Tuohy needle will be insert perpendicular to skin directing the needle slightly towards the ipsilateral anterior superior iliac spine just before the closure of peritoneum. After feeling 2 pops of external and internal oblique aponeurosis the drug will be injected after aspiration. The injectate syringes will be prepared under aseptic technique; syringes contained bupivacaine 0.25% 40 ml. Once the plane is reached the surgeon places his hand inside the abdominal cavity at the level of needle insertion to reconfirm needle placement. A bleb is palpated by the surgeon as the injection continues. The back flow of drug after injection is one of the signs that drug has been deposited in the TAP plane
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
the landmark is at the level of umbilicus 8 to 10 cms from midline bilaterally. A tiny nick is made in the skin with a 18G sharp needle to obliterate the cushion effect. Then an 18 G Tuohy needle will be insert perpendicular to skin directing the needle slightly towards the ipsilateral anterior superior iliac spine just before the closure of peritoneum. After feeling 2 pops of external and internal oblique aponeurosis the drug will be injected after aspiration. The injectate syringes will be prepared under aseptic technique syringes contained either normal saline 40 ml. Once the plane is reached the surgeon places his hand inside the abdominal cavity at the level of needle insertion to reconfirm needle placement. A bleb is palpated by the surgeon as the injection continues. The back flow of drug after injection is one of the signs that drug has been deposited in the TAP plane
Intervention Type
Drug
Intervention Name(s)
Transversus abdominus plane block
Other Intervention Name(s)
Regional analgesia
Intervention Description
transversus abdominus plane block using 40 ml of bupivacaine 0.25%
Intervention Type
Drug
Intervention Name(s)
Transversus abdominus plane placebo
Intervention Description
injection of 40 ml of normal saline in the transversus abdominus plane
Primary Outcome Measure Information:
Title
Time to the first opioid analgesic request
Description
when will the patient ask for opioid analgesia after cesarean section
Time Frame
First 24hours after cesarean section
Secondary Outcome Measure Information:
Title
Total analgesic requirements in 24 hours Total opioid analgesic requirements in 24 hours
Description
The number of patients requiring rescue analgesia and the frequency of this analgesia and total analgesic usage will be calculated
Time Frame
first 24hours after cesarean section

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) class I-II Normal singleton pregnancy. With a gestational age of completed 37 weeks or more. Category ІV cesarean section Exclusion Criteria: Under the age of 18 or older than 40 years. Obese patients with a BMI >40. ASA III or ASA IV risk groups Patients with contraindications to spinal anesthesia or history of allergy to bupivacaine. patients who received analgesics in the past 24 hours Infection in the region where the block would be performed. Category І- Ц- Ш cesarean section Refusal to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adel Shafik, MD
Organizational Affiliation
AinShams university
Official's Role
Study Director
Facility Information:
Facility Name
AinShams university maternity hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
1. Ahmad M, Furqan A, Adnan M, Waris S and Yousuf M (2019):
Results Reference
background
PubMed Identifier
30416635
Citation
Canakci E, Gultekin A, Cebeci Z, Hanedan B, Kilinc A. The Analgesic Efficacy of Transverse Abdominis Plane Block versus Epidural Block after Caesarean Delivery: Which One Is Effective? TAP Block? Epidural Block? Pain Res Manag. 2018 Oct 17;2018:3562701. doi: 10.1155/2018/3562701. eCollection 2018.
Results Reference
background
PubMed Identifier
26225500
Citation
Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
Results Reference
background
PubMed Identifier
21498494
Citation
McMorrow RC, Ni Mhuircheartaigh RJ, Ahmed KA, Aslani A, Ng SC, Conrick-Martin I, Dowling JJ, Gaffney A, Loughrey JP, McCaul CL. Comparison of transversus abdominis plane block vs spinal morphine for pain relief after Caesarean section. Br J Anaesth. 2011 May;106(5):706-12. doi: 10.1093/bja/aer061.
Results Reference
background
PubMed Identifier
6226917
Citation
Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
Results Reference
background
Citation
6. Roy R and Pattnaik S (2016):
Results Reference
background
Citation
7. Sriramka B, Sahoo N and Panigrahi S (2012):
Results Reference
background

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Effect of TAP Block on Time Required for First Analgesic Dose After Cesarean Cection Under Spinal Anesthesia

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