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

Phase 2

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Transversus abdominus plane block; Drug: Transversus abdominus plane placebo

• Registration Number: NCT04623632
• Lead Sponsor: Ain Shams Maternity Hospital

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

Study Timeline

• Study Start: 2020-09-20
• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-10
• Primary Completion: 2021-03-20
• Study Completion: 2021-03-20
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-22
• Last Update Posted: 2022-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine	Transversus abdominus plane block	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
Placebo	Transversus abdominus plane placebo	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

Primary Outcome Measures

Name	Time	Method
Time to the first opioid analgesic request	First 24hours after cesarean section	when will the patient ask for opioid analgesia after cesarean section

Secondary Outcome Measures

Name	Time	Method
Total analgesic requirements in 24 hours Total opioid analgesic requirements in 24 hours	first 24hours after cesarean section	The number of patients requiring rescue analgesia and the frequency of this analgesia and total analgesic usage will be calculated

Trial Locations

Locations (1)

AinShams university maternity hospital; 🇪🇬 Cairo, Egypt